Scientist 1/2, Analytical SciencesLocation Novato, California Workstyle Open to Hybrid Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. The Analytical Sciencesdepartment, a part of Technical Development within TechOps, supports all assay needs in Tech Ops. Our scientists and associates are experts in analytics of small molecules, peptides, proteins/enzymes, and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, and assess the capability of our processes by analyzing in-process samples from bioreactors through purification steps to the drug substance and developingrelease assays for transfer to Quality. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients’ lives.
The Analytical Sciences department at BioMarin Pharmaceutical Inc. is seeking aScientist 1/2to join a mass spectrometry-basedteam focused on supporting oligonucleotide, small molecule, gene,and enzyme replacement therapies. The successful candidate will be a self-motivated, independent, and agile scientist who has proven ability to work in a multi-disciplinary and fast-paced environment.
The primary set of responsibilities will be LC and LC/MS based product characterization and analytical method development to support clinical-phase development and commercial process transfer/investigations/optimizations. The selected candidate should possess excellent organizational, analytical and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.
An ideal candidate will have significant experience in HPLC,Mass Spectrometry based assays, analytical method development,and data handling. A good scientific understanding of protein chemistry and biochemistry is essential. Hands-on experience in oligos and small moleculeswith a prior knowledge of ICHand regulatory submission is a plus.
- Development and execution of primarily LC and LC/MS based analytical methods forthe development and characterizationof oligonucleotides, small moleculesand biologics at different clinical stages.
- Development of analytical methods using size exclusion, ion exchange, reverse phase chromatogramsand capillary electrophoresis.
- Provide the data in a quality presentationform (methods, qualification report, development report, memo, comparability report, etc) to support regulatory submissions.
- Present data proactively and regularly in group and department meetings.
- Track progress against project timelines, generate regular status updates and communicate progress and issues to manager.
- Document experiments, data, and findings electronically in an accessible manner for inspections.
- Participate in the general lab and instrument maintenance.
- Expertise in separations science, including but not limited to: RP, IEX, SEC, HILIC, and HIC
- Expertise in mass spectrometry, including ESIand MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ), and standard chromatographic detectors (UV, FLR, ELSD, CAD, RI, MALS)
- Hand-on experience in protein biochemistry (e.g. SDS-PAGE, Western Blot, Immunoprecipitation)
- Strong organizational and communication skills and effective interpersonal skills
- Ability to learn new technologies fast with good problem-solving skills
- Proven technical skills in a cross-functional and collaborative environment
- Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment
- Experience inchromatography and mass spectrometry.
- Knowledge of biopharmaceutical development.
- Knowledge of oligos and small molecules development is a plus.
PhD degree in Biology,Chemistryor related field with 0-2+ years of relevant post-graduate experiences for Scientist 1, or 2-5+ yearsof relevant post-graduate experiences for Scientist 2.
Will report to aPhDSr. Scientistin Analytical Sciences.
May supervise, mentor, and manage Research Associates.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.